Draft Guidance on Expiration Dating of Unit-Dose Repackaged Drugs; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Expiration Dating of Unit- Dose Repackaged Drugs." The draft guidance is a proposed revision of section 480.200 of FDA's Compliance Policy Guide (CPG) (CPG 7132b.11). We are proposing to revise CPG 7132b.11 so that FDA enforcement policy regarding expiration dating of nonsterile unit-dose repackaged drugs under the agency's current good manufacturing practice (CGMP) regulations is substantially comparable to the expiration dating standards for such drugs set forth in the U.S. Pharmacopeia (USP).